Early Stage Non-Small Cell Lung CancerPhase 1/2NCT03050554
SBRT Combined With Avelumab (Anti-PD-L1) for Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing Avelumab and SBRT in people with Early Stage Non-Small Cell Lung Cancer, run by Andrew Sharabi at 2 sites in United States.
Trial summary
The purpose of the study is to determine whether avelumab has an effect on cancer and body in combination with SBRT, a standard treatment for early stage non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Stage Non-Small Cell Lung Cancer
- What is being tested?
- Avelumab and SBRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Oct 2017to 7 Oct 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor(s) to be treated is(are) ≤ 5.0 cm or ≤250 cm3
- Stage I NSCLC and is deemed medically inoperable or refuses surgical resection.
- Life expectancy ≥ 9 months.
- Acceptable organ and marrow function
Who cannot join
- Prior organ transplantation, including allogeneic stem cell transplantation
- Significant acute or chronic infections including:
- Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Known history of HBV or HCV
- Active autoimmune disease
- Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
Show all 17Show fewer
- Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day
- Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable
- Current use of immunosuppressive medication, EXCEPT for the following:
- intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection)
- Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
- Cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication.
- Known severe hypersensitivity reactions to monoclonal antibodies any history of anaphylaxis, or uncontrolled asthma
- Pregnancy or lactation
- Known alcohol or drug abuse
- Prior radiotherapy to the treatment site(s).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Sanford Health
Sioux Falls, South Dakota, 57104
About this study
Official title: Phase I/II Study of the Safety, Tolerability, and Efficacy of Stereotactic Body Radiation Therapy (SBRT) Combined With Concurrent and Adjuvant Avelumab for Definitive Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
The purpose of the study is to determine whether avelumab has an effect on cancer and body in combination with SBRT, a standard treatment for early stage non-small cell lung cancer (NSCLC).
Avelumab is considered experimental because it is not approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize, target and bind to specific proteins on the cells that make up your tissues. Avelumab is designed to block the interaction between PD-1, a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be stimulated, allowing it to more effectively recognize and attack the cancer.
Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise targeting to deliver a high dose of radiation to the tumor over a short period of time. A positioning cushion such as Vac-lok will be used during radiation treatment that is custom made. This custom mold forms to the contours of the subjects body to allow for proper positioning comfort and stability.
Read the detailed description
This is a single arm open label Phase I/II study that will consist of two parts. In Phase I, investigators will assess the safety and tolerability of SBRT combined with Avelumab. In Phase II, investigators will determine whether SBRT combined with Avelumab improves relapse free survival. Subjects with Stage I NSCLC who are not undergoing surgical resection will be candidates for enrollment. Subjects will receive definitive stereotactic body radiation (SBRT) in 4-5 fractions combined with concurrent and adjuvant Avelumab at 10mg/kg for a total of 6 cycles. Subjects will be evaluated for safety as measured by the occurrence of adverse events, serious adverse events, and laboratory abnormalities. Three blood draws will be obtained to analyze anti-tumor immune responses and immune correlates.
- Conditions
- Early Stage Non-Small Cell Lung Cancer
- Keywords
- cancer, Non-Small Cell Lung Cancer, SBRT, Avelumab, Stereotactic Body Radiation Therapy, radiation, NSCLC, PD-1, PD-L1, Immunotherapy, Lung
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Also called Bavencio
Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles
SBRTRadiation
Also called Stereotactic Body Radiation Therapy
SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
| Study group | Role | What they receive |
|---|---|---|
| SBRT+Avelumab | Experimental | SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles Receives: Drug: Avelumab; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events).
Measured: 6 months
Relapse Free Survival (RFS)
Relapse-Free Survival (RFS) is defined as the time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first. Death is considered as an event here.
Measured: 3 years
Secondary outcomes (2)
Loco-regional Control (LRC)
Locoregional Control (LRC) is defined as the time from starting treatment until local and/or regional relapse is documented
Measured: 3 years
Overall Survival in Patients After Completion of SBRT in Combination With Avelumab
Overall survival in patients is defined as the time from after completion of SBRT in combination with Avelumab
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start26 Oct 2017
- Primary completion7 Oct 2019
- Study completion7 Oct 2019
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Early Stage Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Sharabi
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Andrew Sharabi, University of California, San Diego
- Investigators
- Andrew Sharabi, M.D., Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050554
- Sponsor's protocol ID
- 161591
- Status last verified
- Aug 2024
- First submitted
- 2 Feb 2017
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Safety, Tolerability, and Efficacy of Stereotactic Body Radiation Therapy (SBRT) Combined With Concurrent and Adjuvant Avelumab for Definitive Management of Early Stage Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03050554
- Acronym / sponsor ID
- 161591
- Conditions
- Early Stage Non-Small Cell Lung Cancer
- Keywords
- cancer, Non-Small Cell Lung Cancer, SBRT, Avelumab, Stereotactic Body Radiation Therapy, radiation, NSCLC, PD-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Andrew SharabiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether avelumab has an effect on cancer and body in combination with SBRT, a standard treatment for early stage non-small cell lung cancer (NSCLC).
Avelumab is considered experimental because it is not approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of cancer. It is a type of drug called a monoclonal antibody (a type of protein). Monoclonal antibodies are made to recognize, target and bind to specific proteins on the cells that make up your tissues. Avelumab is designed to block the interaction between PD-1, a known immune checkpoint, and PD-L1. By blocking this interaction, the immune system may be stimulated, allowing it to more effectively recognize and attack the cancer.
Stereotactic Body Radiation Therapy (SBRT) is a type of radiation that uses precise targeting to deliver a high dose of radiation to the tumor over a short period of time. A positioning cushion such as Vac-lok will be used during radiation treatment that is custom made. This custom mold forms to the contours of the subjects body to allow for proper positioning comfort and stability.
Detailed description
This is a single arm open label Phase I/II study that will consist of two parts. In Phase I, investigators will assess the safety and tolerability of SBRT combined with Avelumab. In Phase II, investigators will determine whether SBRT combined with Avelumab improves relapse free survival. Subjects with Stage I NSCLC who are not undergoing surgical resection will be candidates for enrollment. Subjects will receive definitive stereotactic body radiation (SBRT) in 4-5 fractions combined with concurrent and adjuvant Avelumab at 10mg/kg for a total of 6 cycles. Subjects will be evaluated for safety as measured by the occurrence of adverse events, serious adverse events, and laboratory abnormalities. Three blood draws will be obtained to analyze anti-tumor immune responses and immune correlates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+Avelumab | Experimental | Drug: Avelumab, Radiation: SBRTSBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.) Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Tumor(s) to be treated is(are) ≤ 5.0 cm or ≤250 cm3
- Stage I NSCLC and is deemed medically inoperable or refuses surgical resection.
- Life expectancy ≥ 9 months.
- Acceptable organ and marrow function
Key exclusion criteria (17 listed)
- Prior organ transplantation, including allogeneic stem cell transplantation
- Significant acute or chronic infections including:
- Active autoimmune disease
- Current use of immunosuppressive medication, EXCEPT for the following:
- Cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAlso: BavencioAvelumab 10mg/kg IV infusion every 2 weeks for 6 cycles | Drug | SBRT+Avelumab |
| SBRTAlso: Stereotactic Body Radiation TherapySBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.) | Radiation | SBRT+Avelumab |
Primary outcome
Adverse Events
Time frame: 6 months
Safety and tolerability of definitive SBRT combined with concurrent and adjuvant Avelumab in patients with early stage NSCLC (Measured Via Adverse Events).
Relapse Free Survival (RFS)
Time frame: 3 years
Relapse-Free Survival (RFS) is defined as the time from starting treatment to the time of first documented tumor progression or death due to any cause, whichever occurs first. Death is considered as an event here.
2 secondary outcomes
Loco-regional Control (LRC)
Time frame: 3 years
Overall Survival in Patients After Completion of SBRT in Combination With Avelumab
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Sharabi, M.D., Ph.D. principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Avelumab and SBRT in people with Early Stage Non-Small Cell Lung Cancer, run by Andrew Sharabi at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.